Adial Pharmaceuticals (ADIL) 10-Q13 Nov 202020 Q3 Quarterly reportFinancial data

Company Profile

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2020	Nov. 13, 2020
Document and Entity Information [Abstract]
Entity Registrant Name	ADIAL PHARMACEUTICALS, INC.
Entity Central Index Key	0001513525
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Type	10-Q
Document Period End Date	Sep. 30, 2020
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2020
Entity Filer Category	Non-accelerated Filer
Entity Current Reporting Status	Yes
Entity Small Business	true
Entity Shell Company	false
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Common Stock, Shares Outstanding		14,218,100
Entity File Number	001-38323
Entity Interactive Data Current	Yes
Entity Incorporation, State or Country Code	DE

Condensed Balance Sheets (Unaud

Condensed Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Current Assets:
Cash and cash equivalents	$ 7,365,154	$ 6,777,052
Prepaid research and development	214,409	536,916
Prepaid expenses and other current assets	592,829	359,499
Total Current Assets	8,172,392	7,673,467
Intangible assets, net	5,747	6,170
Total Other Assets	5,747	6,170
Total Assets	8,178,139	7,679,637
Current Liabilities:
Accounts payable	247,400	190,204
Accrued expenses	845,594	348,847
Total Current Liabilities	1,092,994	539,051
Commitments and contingencies
Shareholders' Equity
Preferred Stock, 5,000,000 shares authorized with a par value of $0.001 per share, 0 shares outstanding at September 30, 2020 and December 31, 2019
Common Stock, 50,000,000 shares authorized with a par value of $0.001 per share, 14,218,100 and 10,368,352 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	14,218	10,368
Additional paid in capital	35,121,468	27,757,017
Accumulated deficit	(28,050,541)	(20,626,799)
Total Shareholders' Equity	7,085,145	7,140,586
Total Liabilities and Shareholders' Equity	$ 8,178,139	$ 7,679,637

Condensed Balance Sheets (Una_2

Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	50,000,000	50,000,000
Common stock, shares issued	14,218,100	10,368,352
Common stock, shares outstanding	14,218,100	10,368,352

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
Condensed Statements of Operations (Unaudited) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Operating Expenses:
Research and development expenses	$ 1,847,178	$ 864,280	$ 3,789,800	$ 2,761,630
General and administrative expenses	1,491,173	881,462	3,667,588	3,392,388
Total Operating Expenses	3,338,351	1,745,742	7,457,388	6,154,018
Loss From Operations	(3,338,351)	(1,745,742)	(7,457,388)	(6,154,018)
Other Income (Expense)
Interest income	2,532	29,859	31,146	62,840
Other income			2,500
Warrant modification expense				(441,763)
Total other income (expense)	2,532	29,859	33,646	(378,923)
Loss Before Provision For Income Taxes	(3,335,819)	(1,715,883)	(7,423,742)	(6,532,941)
Provision for income taxes
Net Loss	$ (3,335,819)	$ (1,715,883)	$ (7,423,742)	$ (6,532,941)
Net loss per share, basic and diluted	$ (0.24)	$ (0.17)	$ (0.63)	$ (0.68)
Weighted average shares, basic and diluted	13,646,153	10,252,458	11,825,179	9,599,211

Condensed Consolidated Statemen

Condensed Consolidated Statements of Shareholders' Equity (Unaudited) - USD ($)	Common Stock	Additional Paid In Capital	Accumulated Deficit	Total
Balance at Dec. 31, 2018	$ 6,863	$ 16,469,818	$ (12,035,370)	$ 4,441,311
Balance, shares at Dec. 31, 2018	6,862,499
Equity-based compensation - stock option expense		129,150		129,150
Equity-based compensation - stock issuances to consultants	$ 94	154,760		154,854
Equity-based compensation - stock issuances to consultants, shares	93,750
Warrant modification expense		441,763		441,763
Sale of Common Stock & Warrants, net of expenses	$ 2,845	9,243,404		9,246,249
Sale of Common Stock & Warrants	2,845,000
Offering Issuance Cost		(1,050,576)		(1,050,576)
Exercise of warrants	$ 367	1,050,270		1,050,637
Exercise of warrants, shares	367,577
Net loss			(2,682,651)	(2,682,651)
Balance at Mar. 31, 2019	$ 10,169	26,438,589	(14,718,021)	11,730,737
Balance, shares at Mar. 31, 2019	10,168,826
Equity-based compensation - stock option expense		310,210		310,210
Equity-based compensation - stock issuances to consultants	$ 69	154,181		154,250
Equity-based compensation - stock issuances to consultants, shares	68,750
Exercise of warrants	$ 4	22		26
Exercise of warrants, shares	4,873
Net loss			(2,134,407)	(2,134,407)
Balance at Jun. 30, 2019	$ 10,242	26,903,002	$ (16,852,428)	10,060,816
Balance, shares at Jun. 30, 2019	10,242,449
Equity-based compensation - stock option expense		313,619		313,619
Equity-based compensation - stock issuances to consultants	$ 19	71,231		71,250
Equity-based compensation - stock issuances to consultants, shares	18,750
Exercise of warrants	$ 34	144		$ 178
Exercise of warrants, shares	33,661
Sale of common stock, net of expenses, shares			(1,715,883)	(1,715,883)
Balance at Sep. 30, 2019	$ 10,295	27,287,996	$ (18,568,311)	$ 8,729,980
Balance, shares at Sep. 30, 2019	10,294,860
Balance at Dec. 31, 2019	$ 10,368	27,757,017	(20,626,799)	7,140,586
Balance, shares at Dec. 31, 2019	10,368,352
Equity-based compensation - stock option expense		342,007		342,007
Equity-based compensation - stock and warrant issuances to consultants and employees	$ 261	345,366		345,627
Equity-based compensation - stock and warrant issuances to consultants and employees, shares	261,251
Net loss			(2,276,813)	(2,276,813)
Balance at Mar. 31, 2020	$ 10,629	28,444,390	(22,903,612)	5,551,407
Balance, shares at Mar. 31, 2020	10,629,603
Equity-based compensation - stock option expense		385,648		385,648
Equity-based compensation - stock and warrant issuances to consultants and employees		9,804		9,804
Equity-based compensation - stock and warrant issuances to consultants and employees, shares
Sale of common stock, net of expenses	$ 2,820	4,654,395		4,657,215
Sale of common stock, net of expenses, shares	2,820,000
Net loss			(1,811,110)	(1,811,110)
Balance at Jun. 30, 2020	$ 13,449	33,494,237	(24,714,722)	7,085,145
Balance, shares at Jun. 30, 2020	13,449,603
Equity-based compensation - stock option expense		348,185		348,185
Equity-based compensation - stock and warrant issuances to consultants and employees	$ 185	329,622		329,807
Equity-based compensation - stock and warrant issuances to consultants and employees, shares	185,000
Exercise of warrants	$ 227	449,781		450,008
Exercise of warrants, shares	226,354
Sale of common stock, net of expenses	$ 357	499,643		500,000
Sale of common stock, net of expenses, shares	357,143
Net loss			(3,335,819)	(3,335,819)
Balance at Sep. 30, 2020	$ 14,218	$ 35,121,468	$ (28,050,541)	$ 7,085,145
Balance, shares at Sep. 30, 2020	14,218,100

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
Condensed Statements of Cash Flows (Unaudited) - USD ($)	Sep. 30, 2020	Sep. 30, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (7,423,742)	$ (6,532,941)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation	1,644,077	1,133,333
Non-cash warrant modification expense		441,763
Amortization of intangible assets	423	424
Changes in operating assets and liabilities:
Prepaid research and development expenses	322,507	45,905
Prepaid expenses and other current assets	(233,330)	(193,332)
Accrued expenses	613,748	133,995
Accounts payable	57,196	384,977
Net cash used in operating activities	(5,019,121)	(4,585,876)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock and warrants	5,157,215	8,195,673
Proceeds from warrant exercise	450,008	1,050,841
Net cash provided by financing activities	5,607,223	9,246,514
NET INCREASE IN CASH AND CASH EQUIVALENTS	588,102	4,660,638
CASH AND CASH EQUIVALENTS-BEGINNING OF PERIOD	6,777,052	3,869,043
CASH AND CASH EQUIVALENTS-END OF PERIOD	7,365,154	8,529,681
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid
Income taxes paid
Reclassification of stock-based comp from accrued expenses	$ 117,001

Description of Business

Description of Business	9 Months Ended
Description of Business	Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
DESCRIPTION OF BUSINESS	1 — DESCRIPTION OF BUSINESS Adial Pharmaceuticals, Inc. (the “Company” or “Adial”) was converted from a limited liability company formed under the name ADial Pharmaceuticals, LLC, formed on November 23, 2010 in the Commonwealth of Virginia to a corporation and reincorporated in Delaware on October 1, 2017. Adial is presently engaged in the development of medications for the treatment of addictions and related disorders. The Company has commenced its first Phase 3 clinical trial of its lead compound AD04 (“AD04”) for the treatment of alcohol use disorder. Both the U.S. Food and Drug Administration (“FDA”) and the European Medicines Authority (“EMA”) have indicated they will accept heavy-drinking-based endpoints as a basis for approval for the treatment of alcohol use disorder rather than the previously required abstinence-based endpoints. Key patents have been issued in the United States, the European Union, and other jurisdictions for which the Company has exclusive license rights. The active ingredient in AD04 is ondansetron, a serotonin-3 antagonist. Due to its mechanism of action, AD04 has the potential to be used for the treatment of other addictive disorders, such as opioid use disorder, obesity, smoking, and other drug addictions. On June 11, 2020, the Company concluded a registered direct offering of 2,820,000 shares of common stock and in a concurrent private placement the sale of warrants to purchase 2,115,000 shares of common stock at an exercise price of $2.00 per share. The shares of common stock and accompanying warrants were sold at a combined at-the-market price of $1.85 for a share and three quarters warrant. Gross proceeds of the offering, totaled $5,217,000, which after offering expenses, resulted in net proceeds of $4,657,215. On September 21, 2020, the Company concluded a private placement of 357,143 shares of common stock at an above market price of $1.40 per share. Gross proceeds of the offering totaled $500,000, with no material expenses.

Liquidity, Going Concern and Ot

Liquidity, Going Concern and Other Uncertainties	9 Months Ended
Liquidity, Going Concern and Other Uncertainties	Sep. 30, 2020
Liquidity Going Concern and Other Uncertainties [Abstract]
LIQUIDITY, GOING CONCERN AND OTHER UNCERTAINTIES	2 — LIQUIDITY, GOING CONCERN AND OTHER UNCERTAINTIES The unaudited condensed financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“GAAP”), which contemplate continuation of the Company as a going concern. The Company is in a development stage and has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception and has an accumulated deficit of approximately $28.1 million as of September 30, 2020. Based on the current development plans for AD04 in both the U.S. and international markets and other operating requirements, the Company does not believe that the existing cash and equivalents are sufficient to fund operations for the next twelve months following the filing of these unaudited condensed financial statements, though the Company expects cash on hand to be sufficient to fund operations to the end of the third quarter of 2021. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Due to the COVID-19 pandemic, during the first three quarters of 2020, the Company experienced delays in certain countries in obtaining regulatory approval required to commence the trial in such countries, resulting in significantly slowed trial enrollment (see Other Uncertainties The Company’s plans include raising additional capital from various potential sources, including equity and/or debt financings, grant funding, and strategic relationships. Although management is actively pursuing financing and other strategic plans, there are no assurances that such financing or other strategic plans will be available on acceptable terms, or at all. Without additional funding, the Company would be required to delay, scale back or eliminate some or all of its research and development programs, which would likely have a material adverse effect on the Company and its financial statements. The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above. Other Uncertainties Generally, the industry in which the Company operates subjects the Company to a number of other risks and uncertainties that can affect its operating results and financial condition. Such factors include, but are not limited to: the timing, costs and results of clinical trials and other development activities versus expectations; the ability to obtain regulatory approval to market product candidates; the ability to manufacture products successfully; competition from products sold or being developed by other companies; the price of, and demand for, Company products once approved; the ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products. The Company also faces the ongoing risk that the coronavirus pandemic may further slow, for an unforeseeable period, the conduct of the Company’s trial. The effects of the ongoing coronavirus pandemic may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and supplier of our active pharmaceutical ingredient. The full extent to which the COVID-19 pandemic impacts the clinical development of AD04, the Company’s suppliers and other commercial partners, will depend on future developments that are still highly uncertain and cannot be predicted with confidence at this time, all of which could have a material adverse effect on our business, financial condition, and results of operations.

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
Summary of Significant Accounting Policies	Sep. 30, 2020
Accounting Policies [Abstract]
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions for Form 10-Q and Article 8 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2019, included in the Annual Report on Form 10-K filed on March 20, 2020. Reclassification Certain prior year and prior quarter amounts have been reclassified for consistency with the current presentation. These reclassifications had no effect on the reported results of operations. Use of Estimates The preparation of unaudited condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation, accruals associated with third party providers supporting clinical trials, and income tax asset realization. In particular, the recognition of clinical trial costs is dependent on our own judgement, as well as the judgment of our contractors and subcontractors in their reporting of information to us. Basic and Diluted Earnings (Loss) per Share Basic and diluted earnings (loss) per share are computed based on the weighted-average outstanding shares of common stock, which are all voting shares. Diluted net loss per share is computed giving effect to all proportional shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2020 and 2019 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect. The total potentially dilutive common shares that were excluded for the nine and three month periods ended September 30, 2020 and 2019 were as follows: Potentially Dilutive Common 2020 2019 Warrants to purchase Common Shares, less "penny warrants" included in potentially dilutive common shares 8,557,631 6,689,579 Common Shares issuable on exercise of options 2,668,866 1,400,967 Total potentially dilutive Common Shares excluded 11,226,497 8,090,546 Research and Development Research and development costs are charged to expense as incurred and include direct trial expenses such as fees due to contract research organizations, consultants which support the Company's research and development endeavors, the acquisition of technology rights without an alternative use, and compensation and benefits of clinical research and development personnel. Certain research and development costs, in particular fees to contract research organizations ("CROs"), are structured with milestone payments due on the occurrence of certain key events. Where such milestone payments are greater than those earned through the provision of such services, the Company recognizes a prepaid asset which is recorded as expense as services are incurred. Stock-Based Compensation The Company measures the cost of option awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the awardee was required to provide service in exchange for the entire award. The fair value of options is calculated using the Black-Scholes option pricing model, based on key assumptions such as the expected volatility of the Company's common stock, the risk-free rate of return, and expected term of the options. The Company's estimates of these assumptions are primarily based on historical data, peer company data, government data, and the judgment of management regarding future trends. Common shares issued are valued based on the fair value of the Company's common shares as determined by the market closing price of a share of our common stock on the date of the commitment to make the issuance. Income Taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and tax carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established to reduce net deferred tax assets to the amount expected to be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Changes in recognition and measurement are reflected in the period in which the change in judgment occurs. Interest and penalties related to unrecognized tax benefits are included in income tax expense. The Company has generally recorded a full valuation allowance for its tax carryforwards, reflecting the judgment of Company management that they are more likely than not to expire unused. Adoption of Recent Accounting Pronouncements Fair Value

Accrued Expenses

Accrued Expenses	9 Months Ended
Accrued Expenses	Sep. 30, 2020
Payables and Accruals [Abstract]
ACCRUED EXPENSES	4 — ACCRUED EXPENSES Accrued expenses consist of the following: September 30, December 31, Employee compensation $ 182,477 $ 263,914 Legal and consulting services 28,827 68,056 Clinical research organization services and expenses 590,290 16,877 Manufacturing expenses 14,000 – Minimum license royalties 30,000 – Total accrued expenses $ 845,594 $ 348,847

Related Party Transactions

Related Party Transactions	9 Months Ended
Related Party Transactions	Sep. 30, 2020
Related Party Transactions [Abstract]
RELATED PARTY TRANSACTIONS	5 — RELATED PARTY TRANSACTIONS In January 2011, the Company entered into an exclusive, worldwide license agreement with The University of Virginia Patent Foundation d/b/a the University of Virginia Licensing and Ventures Group (the "UVA LVG") for rights to make, use or sell licensed products in the United States based upon patents and patent applications made and held by UVA LVG (the "UVA LVG License"). The Company is required to pay compensation to the UVA LVG, as described Note 7. A certain percentage of these payments by the Company to the UVA LVG may then be distributed to the Company's former Chairman of the Board who currently serves as the Company's Chief Medical Officer in his capacity as inventor of the patents by the UVA LVG in accordance with their policies at the time. See Note 7 for related party vendor, consulting, and lease agreements.

Shareholders' Equity

Shareholders' Equity	9 Months Ended
Shareholders' Equity	Sep. 30, 2020
Equity [Abstract]
SHAREHOLDERS' EQUITY	6 — SHAREHOLDERS' EQUITY Common Stock Issuances On January 22, 2019, the Company issued 250,000 unregistered shares of common stock upon the exercise of a warrant to purchase 300,000 shares of common stock at an exercise price of $3.75 per share for a cash payment of $468,750 and the cashless exercise of the remaining warrant. On January 31, 2019, the Company issued 22,311 unregistered shares of common stock upon the full cashless exercise of a warrant to purchase 65,130 shares of common stock at an exercise price of $4.99 per share. On February 22, 2019, the Company concluded a follow-on offering of 2,475,000 shares of common stock and warrants to purchase 1,856,250 shares of common stock at an exercise price of $4.0625 per share. The shares of common stock and accompanying warrants were sold to the public at a price of $3.25 per share and warrant. The underwriters were granted an over-allotment option to purchase up to 371,250 shares of common stock and warrants to purchase 278,437 shares of common stock at a price of $3.25 per share of common stock and warrant. The underwriters partially exercised their over-allotment option by purchasing 370,000 shares of common stock and warrants to purchase 277,500 shares common stock. Gross proceeds of the offering, totaled $9,246,249, which after offering expenses, resulted in net proceeds of $8,195,673. On March 3, 2020, the Compensation Committee of Board of Directors of the Company awarded the Company's executive officers, William B. Stilley, Chief Executive Officer, and Joseph Truluck, Chief Financial Officer, performance bonuses for 2019, partially paid in common stock of the Company to preserve cash, of $42,000 and $21,000 in cash, respectively, and 54,167 and 27,084 shares of the Company's common stock, respectively, which shares are subject to a six-month contractual restriction on sale. Of the $180,002 total cost of these bonuses, $150,000 were recognized in the year ended December 31, 2019 as expected under these executives' contracts, and the remaining $30,002 in bonus was recognized upon Board approval. On June 11, 2020, the Company concluded a registered direct offering of 2,820,000 shares of common stock and in a concurrent private placement the sale of warrants to purchase 2,115,000 shares of common stock at an exercise price of $2.00 per share. The shares of common stock and accompanying warrants were sold directly to the buyers at a combined at-the-market price of $1.85 for a share and three quarters warrant. Gross proceeds of the offering, totaled $5,217,000, which after offering expenses, resulted in net proceeds of $4,657,215. On July 31, 2020, warrants to purchase 1,354 shares at an exercise price of $0.005 per share were exercised for a cash payment of $8. On September 21, 2020, the Company concluded a private placement of 357,143 unregistered shares of common stock and above market price of $1.40 per share. Gross proceeds of the offering, totaled $500,000, with no material expenses. On September 29, 2020, previously registered warrants to purchase 225,000 shares at an exercise fee of $2.00 per share were exercised for a total of $450,000. During the nine months ended September 30, 2020, the Company issued 446,251 shares of common stock to consultants for services rendered and to employees at a total cost of $655,827. 2017 Equity Incentive Plan On October 9, 2017, the Company adopted the Adial Pharmaceuticals, Inc. 2017 Equity Incentive Plan (the "2017 Equity Incentive Plan"); which became effective on July 31, 2018. Initially, the aggregate number of shares of our common stock that may be issued pursuant to stock awards under the 2017 Equity Incentive Plan was 1,750,000 shares. On September 1, 2020, by a vote of the shareholders, the number of shares issuable under the 2017 Equity Incentive Plan was increased to 5,500,000. At September 30, 2020, the Company had issued 799,438 shares and had outstanding 2,529,180 options to purchase shares of our common stock under the 2017 Equity Incentive Plan. Stock Options The following table provides the stock option activity for the nine months ended September 30, 2020: Total Weighted Weighted Weighted Outstanding December 31, 2019 1,661,466 9.14 3.38 2.38 Issued 1,255,000 1.44 1.13 Cancelled (247,600 ) 3.27 2.04 Outstanding September 30, 2020 2,668,866 8.34 2.48 1.78 Outstanding September 30, 2020, vested and exercisable 1,037,227 7.85 $ 2.63 $ 2.22 At September 30, 2020, the intrinsic value totals of the outstanding options were $1,051,006. The Company used the Black Scholes valuation model to determine the fair value of the options issued, using the following key assumptions for the nine months ended September 30, 2020: September 30, Fair Value per Share $ 1.36-1.48 Expected Term 5.75 years Expected Dividend $ – Expected Volatility 102.39-103.83 % Risk free rate 0.49-0.72 % During the nine months ended September 30, 2020, 1,255,000 options to purchase shares of common stock were granted at a fair value of $1,420,505, an approximate weighted average fair value of $1.13 per option, to be amortized over a service a weighted average period of three years. As of September 30, 2020, $2,688,650 in unrecognized compensation expense will be recognized over a weighted average remaining service period of 1.82 years. The components of stock-based compensation expense included in the Company's Statements of Operations for the three and nine months ended September 30, 2020 and 2019 are as follows: Three months ended Nine months ended 2020 2019 2020 2019 Research and development options expense 56,458 99,612 196,976 241,315 Total research and development expenses 56,458 99,612 196,976 241,315 General and administrative options expense 291,727 214,007 878,864 511,664 Stock and warrants issued to consultants and employees 329,807 71,250 685,238 380,354 Total general and administrative expenses 621,534 285,257 1,564,102 892,018 Total stock-based compensation expense $ 677,992 $ 384,869 $ 1,761,078 $ 1,133,333 Stock Warrants The following table provides the activity in warrants for the respective periods. Total Warrants Weighted Weighted Average Exercise Price Average Outstanding December 31, 2019 6,669,274 4.23 $ 5.38 0.03 Issued 2,187,000 1.98 Exercised (226,354 ) 1.99 Outstanding September 30, 2020 8,629,920 4.88 $ 4.61 0.08 This table includes warrant to purchase 72,000 shares of common stock issued to a consultant, with a total fair value of $73,914 at time of issue, calculated using the Black Scholes model assuming an underlying security value of $1.30 and volatility rate of 103.83%, a risk-free rate of 0.49%, and an expected term of 5.75 years. During the nine months ended September 30, 2020, 226,354 warrants to purchase shares of common stock were exercised for total proceeds of $450,008.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
Commitments and Contingencies	Sep. 30, 2020
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS AND CONTINGENCIES	7 — COMMITMENTS AND CONTINGENCIES License with University of Virginia Patent Foundation In January 2011, the Company entered into an exclusive, worldwide license agreement with (the "UVA LVG") for rights to make, use or sell licensed products in the United States based upon the ten separate patents and patent applications made and held by UVA LVG. As consideration for the rights granted in the UVA LVG License, the Company is obligated to pay UVA LVG yearly license fees and milestone payments, as well as a royalty based on net sales of products covered by the patent-related rights. More specifically, the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense ourselves. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income. The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if the Company breaches its obligations thereunder, including failing to make any milestone, failure to make required payments, or the failure to exercise diligence to bring licensed products to market. In the event of a termination, the Company will be obligated to pay all amounts that accrued prior to such termination. The term of the license continues until the expiration, abandonment or invalidation of all licensed patents and patent applications, and following any such expiration, abandonment or invalidation will continue in perpetuity on a royalty-free, fully paid basis. The Company executed an amendment, dated December 14, 2017, which changed the dates by which the Company, using commercially reasonable efforts, was to achieve the goals of submitting a New Drug Application to the FDA for a licensed product to December 31, 2024 (from December 31, 2023) and commencing commercialization of an FDA approved product by December 31, 2025 (from December 31, 2024). If the Company were to fail to use commercially reasonable effort and fail to meet either goal, the licensor would have the right to terminate the license. The Company executed a further amendment to the license agreement, dated December 18, 2018, changing the date at which the Company must have initiated a Phase 3 trial to December 31, 2019. On December 31, 2019, the Company executed a further amendment to the license agreement which, among other things, removed in its entirety the diligence milestone to initiate a Phase 3 clinical trial by December 31, 2019. Furthermore, the Company agreed to pay upon execution of the amendment the diligence milestone payment of $20,000 that had been due upon initiation of a Phase 3 clinical trial. In addition, the Company agreed to use and will continue to use best efforts to dose a first patient with a Licensed Product (as defined in the License Agreement) in a Phase 3 clinical trial on or before March 31, 2020. In March of 2020, the first patient was dosed with AD04 after having joined the Company's trial, satisfying this term of the license agreement. During the three and nine months ended September 30, 2020, the Company recognized $10,000 and $30,000 minimum license royalty expenses, respectively, under this agreement. Clinical Research Organization (CRO) On October 31, 2018, the Company entered into a master services agreement ("MSA") with Crown CRO Oy ("Crown") for contract clinical research and consulting services. The MSA has a term of five years, automatically renewed for two-year periods, unless either party gives written notice of a decision not to renew the agreement three months prior to automatic renewal. The MSA or a service agreement under it may be terminated by the Company, without penalty, on fourteen days written notice for scientific, administrative, or financial reasons, or if the purpose of the study becomes obsolete. In the event that the MSA or Service Order are terminated, Crown's actual costs up the date of termination will be payable by the Company, but any unrealized milestones would not be owed. On November 16, 2018, the Company and Crown entered into Service Agreement 1 under the MSA for a 24 week, multi-centered, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 clinical study of the Company's lead compound, AD04. On June 28, 2019, the Company and Crown Executed a change order to Service Agreement 1 increasing Crown's fee from $3,470,713 (€2,958,835 converted to dollars at the Euro/US Dollar exchange rate of 1.173 as of September 30, 2020) to $3,717,114 (€3,168,895) and rescheduling future milestone payments as shown below. On November 21, 2018, the Company made the initial prepayment under the agreement of $505,960, after exchange to US dollars at the rate then prevailing. The fees are to be paid as milestones are reached on the following schedule. On September 30, 2019, the Company received an invoice for the 10% milestone payment associated with the first submission of a trial application to a national regulatory authority and recorded a prepaid expense of $294,124. On February 1, 2020, the first site initiation visit ("SIV") of a study site had been completed and the second milestone of €269,938, was recognized as a prepaid expense of $299,496. On February 27, 2020, the first potential patient for the study had been screened and the third milestone payment of €269,938 was recognized as a prepaid expense of $297,013. On June 15, 2020, 50% of sites had been initiated and a fourth milestone payment of €269,938 was recognized as a prepaid expense of $302,843. At September 30, 2020, the remaining future milestone payments are shown in the table below, converted to dollars from euros at the exchange rate then prevailing. Milestone Event Percent Amount 30% patients randomized 10 % $ 316,637 60% patients randomized 10 % $ 316,637 100% sites initiated 10 % $ 316,637 100% of patients randomized 10 % $ 316,637 90% of case report form pages monitored 5 % $ 158,319 PE analysis 5 % $ 158,319 Database is locked 10 % $ 316,637 During the three and nine months ended September 30, 2020, the Company recognized $661,867 and $1,366,478 respectively, in direct expenses associated with the Service Agreement 1, classified as R&D expense. Prepaid R&D costs were $214,633 at December 31, 2019, but on September 30, 2020 the Company had an accrued expense liability of $226,369. Service Agreement 1 also estimated approximately $2.5 million (€2,172,000) in pass-through costs, mostly fees to clinical investigators and sites, which will be billed as incurred and the total contingent upon individual site rate and enrollment rates. Based on current enrollment rates and the various active clinical sites, the Company has increased its total estimated future site costs by €344,768 to a total of approximately $2.9 million (€2,516,768), an estimate that could increase or decrease based on changes to individual site enrollment rates. During the three and nine months ended September 30, 2020, the Company recognized $362,188 and $440,473, respectively, in costs associated with fees to investigators and sites. Lease Commitments – Related Party On March 1, 2020, the Company entered into a sublease with Purnovate, LLC, a private company in which the Company's CEO has a 30% equity interest, for the lease of three offices at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901. The lease has a term of two years, and the monthly rent is $1,400. During the three and nine months ended September 30, 2020, the rent expense associated with this lease was $4,200 and $9,800, respectively. Consulting Agreements – Related Party On March 24, 2019, the Company entered into a consulting agreement (the "Consulting Agreement") with Dr. Bankole A. Johnson, who at the time of the agreement was serving as the Chairman of the Board of Directors, for his service as Chief Medical Officer of the Company. The Consulting Agreement has a term of three years, unless terminated by mutual consent or by the Company for cause. Dr. Johnson resigned as Chairman of the Board of Directors at the time of execution of the consulting agreement. Under the terms of the Consulting Agreement, Dr. Johnson's annual fee of $375,000 per year is paid twice per month. On execution, Dr. Johnson received a signing bonus of $250,000 and option to purchase 250,000 shares of common stock. Dr. Johnson's participation in the Grant Incentive Plan (see below) and 2017 Equity Incentive Plan continue unaffected. The total expense to the Company under this agreement was $93,750 and $281,250 in the three and nine months ended September 30, 2020, respectively. On July 5, 2019, the Company entered into a Master Services Agreement (the "MSA") and attached statement of work with Psychological Education Publishing Company ("PEPCO") to administer a behavioral therapy program during the Company's upcoming Phase 3 clinical trial. PEPCO is owned by a related party, Dr. Bankole Johnson, the Company's Chief Medical Officer, and currently the largest stockholder in the Company. It is anticipated that the compensation to be paid to PEPCO for services under the MSA will total approximately $300,000, of which shares of the Company's common stock having a value equal to twenty percent (20%) of this total can be issued to Dr. Johnson in lieu of cash payment. On December 12, 2019, the Company entered into an Amendment (the "Amendment") to the statement of work ("SOW"). The Company had paid PEPCO $39,064 under the SOW for services rendered as of the Amendment date, leaving as estimated balance of $274,779 to be paid under the SOW. The Amendment provided the Company with a 20% discount on the remaining fees owed for services and fixed the price of any remaining services at a total of $219,823 for all services required for the use of Brief Behavioral Compliance Enhancement Treatment (BBCET) in support of the Trial. In addition, Dr. Johnson executed a guaranty, dated December 12, 2019, of PEPCO's performance under the MSA and SOW (the "Guaranty"), together with a pledge and security agreement, dated December 12, 2019 (the "Pledge and Security Agreement"), to secure the Guaranty with 600,000 shares of the Company's common stock beneficially owned by him and a lock-up agreement, dated December 12, 2019 (the "Lock-Up"), pursuant to which he agreed not to transfer or dispose of, directly or indirectly, any shares of the Company's common stock, as currently owned by him, until after January 1, 2021. On August 19, 2020, we entered into a Lock-Up Agreement Extension and Right of First Refusal with Dr. Johnson (the "Lock-Up Extension"), which amended the Lock-Up Agreement that had been entered into dated December 12, 2019 (the "Lock-Up"). The Lock-Up Extension extended the term of Dr. Johnson's Lock-Up from January 1, 2021 until April 1, 2021. In connection with the Lock-Up Extension, Dr. Johnson was released from his Lock-Up restrictions with respect to 350,000 shares of the Company's common stock. During the three and nine months ended September 30, 2020, the Company recognized $18,628 and $108,056, respectively, in expenses associated with this vendor agreement. As of September 30, 2020, the Company had recognized $147,120 in expenses, of which $108,056 were charged against cash advanced under the terms of the Amendment, leaving a net prepaid expense asset of $111,767 associated with this vendor agreement. Litigation The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company's liquidity, financial condition and cash flows. At September 30, 2020, the Company did not have any pending legal actions.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2020
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions for Form 10-Q and Article 8 of Regulation S-X. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2019, included in the Annual Report on Form 10-K filed on March 20, 2020.
Reclassification	Reclassification Certain prior year and prior quarter amounts have been reclassified for consistency with the current presentation. These reclassifications had no effect on the reported results of operations.
Use of Estimates	Use of Estimates The preparation of unaudited condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant items subject to such estimates and assumptions include the valuation of stock-based compensation, accruals associated with third party providers supporting clinical trials, and income tax asset realization. In particular, the recognition of clinical trial costs is dependent on our own judgement, as well as the judgment of our contractors and subcontractors in their reporting of information to us.
Basic and Diluted Earnings (Loss) per Share	Basic and Diluted Earnings (Loss) per Share Basic and diluted earnings (loss) per share are computed based on the weighted-average outstanding shares of common stock, which are all voting shares. Diluted net loss per share is computed giving effect to all proportional shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2020 and 2019 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect. The total potentially dilutive common shares that were excluded for the nine and three month periods ended September 30, 2020 and 2019 were as follows: Potentially Dilutive Common 2020 2019 Warrants to purchase Common Shares, less "penny warrants" included in potentially dilutive common shares 8,557,631 6,689,579 Common Shares issuable on exercise of options 2,668,866 1,400,967 Total potentially dilutive Common Shares excluded 11,226,497 8,090,546
Research and Development	Research and Development Research and development costs are charged to expense as incurred and include direct trial expenses such as fees due to contract research organizations, consultants which support the Company's research and development endeavors, the acquisition of technology rights without an alternative use, and compensation and benefits of clinical research and development personnel. Certain research and development costs, in particular fees to contract research organizations ("CROs"), are structured with milestone payments due on the occurrence of certain key events. Where such milestone payments are greater than those earned through the provision of such services, the Company recognizes a prepaid asset which is recorded as expense as services are incurred.
Stock-Based Compensation	Stock-Based Compensation The Company measures the cost of option awards based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the awardee was required to provide service in exchange for the entire award. The fair value of options is calculated using the Black-Scholes option pricing model, based on key assumptions such as the expected volatility of the Company's common stock, the risk-free rate of return, and expected term of the options. The Company's estimates of these assumptions are primarily based on historical data, peer company data, government data, and the judgment of management regarding future trends. Common shares issued are valued based on the fair value of the Company's common shares as determined by the market closing price of a share of our common stock on the date of the commitment to make the issuance.
Income Taxes	Income Taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and tax carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is established to reduce net deferred tax assets to the amount expected to be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Changes in recognition and measurement are reflected in the period in which the change in judgment occurs. Interest and penalties related to unrecognized tax benefits are included in income tax expense. The Company has generally recorded a full valuation allowance for its tax carryforwards, reflecting the judgment of Company management that they are more likely than not to expire unused.
Adoption of Recent Accounting Pronouncements	Adoption of Recent Accounting Pronouncements Fair Value

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Tables)	9 Months Ended
Summary of Significant Accounting Policies (Tables)	Sep. 30, 2020
Accounting Policies [Abstract]
Schedule of potentially dilutive common shares	Potentially Dilutive Common 2020 2019 Warrants to purchase Common Shares, less "penny warrants" included in potentially dilutive common shares 8,557,631 6,689,579 Common Shares issuable on exercise of options 2,668,866 1,400,967 Total potentially dilutive Common Shares excluded 11,226,497 8,090,546

Accrued Expenses (Tables)

Accrued Expenses (Tables)	9 Months Ended
Accrued Expenses (Tables)	Sep. 30, 2020
Payables and Accruals [Abstract]
Schedule of accrued liabilties	September 30, December 31, Employee compensation $ 182,477 $ 263,914 Legal and consulting services 28,827 68,056 Clinical research organization services and expenses 590,290 16,877 Manufacturing expenses 14,000 – Minimum license royalties 30,000 – Total accrued expenses $ 845,594 $ 348,847

Shareholders' Equity (Tables)

Shareholders' Equity (Tables)	9 Months Ended
Shareholders' Equity (Tables)	Sep. 30, 2020
Equity [Abstract]
Schedule of stock options activity	Total Weighted Weighted Weighted Outstanding December 31, 2019 1,661,466 9.14 3.38 2.38 Issued 1,255,000 1.44 1.13 Cancelled (247,600 ) 3.27 2.04 Outstanding September 30, 2020 2,668,866 8.34 2.48 1.78 Outstanding September 30, 2020, vested and exercisable 1,037,227 7.85 $ 2.63 $ 2.22
Schedule of black scholes valuation model to determine the fair value of the options issued	September 30, Fair Value per Share $ 1.36-1.48 Expected Term 5.75 years Expected Dividend $ – Expected Volatility 102.39-103.83 % Risk free rate 0.49-0.72 %
Schedule of stock-based compensation expense	Three months ended Nine months ended 2020 2019 2020 2019 Research and development options expense 56,458 99,612 196,976 241,315 Total research and development expenses 56,458 99,612 196,976 241,315 General and administrative options expense 291,727 214,007 878,864 511,664 Stock and warrants issued to consultants and employees 329,807 71,250 685,238 380,354 Total general and administrative expenses 621,534 285,257 1,564,102 892,018 Total stock-based compensation expense $ 677,992 $ 384,869 $ 1,761,078 $ 1,133,333
Schedule of activity in warrants	Total Warrants Weighted Weighted Average Exercise Price Average Outstanding December 31, 2019 6,669,274 4.23 $ 5.38 0.03 Issued 2,187,000 1.98 Exercised (226,354 ) 1.99 Outstanding September 30, 2020 8,629,920 4.88 $ 4.61 0.08

Commitments and Contingencies (

Commitments and Contingencies (Tables)	9 Months Ended
Commitments and Contingencies (Tables)	Sep. 30, 2020
Commitments and Contingencies Disclosure [Abstract]
Schedule of remaining future milestone payments	Milestone Event Percent Amount 30% patients randomized 10 % $ 316,637 60% patients randomized 10 % $ 316,637 100% sites initiated 10 % $ 316,637 100% of patients randomized 10 % $ 316,637 90% of case report form pages monitored 5 % $ 158,319 PE analysis 5 % $ 158,319 Database is locked 10 % $ 316,637

Description of Business (Detail

Description of Business (Details) - USD ($)	Sep. 21, 2020	Jun. 11, 2020	Jan. 31, 2019	Jan. 22, 2019	Sep. 30, 2020
Description of Business (Textual)
Incorporation of business, date					Oct. 1, 2017
Incorporation country name					Delaware
Direct offering shares		2,820,000	22,311	250,000
Warrants for purchase of common stock		$ 2,115,000
Common stock exercise price		$ 2
Common stock market price		$ 1.85
Proceeds of offering, description	Gross proceeds of the offering totaled $500,000, with no material expenses.	Gross proceeds of the offering, totaled $5,217,000, which after offering expenses, resulted in net proceeds of $4,657,215.
Private Placement [Member] \| Common Stock
Description of Business (Textual)
Warrants for purchase of common stock	$ 357,143
Common stock market price	$ 1.40

Liquidity, Going Concern and _2

Liquidity, Going Concern and Other Uncertainties (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Liquidity, Going Concern and Other Uncertainties (Textual)
Accumulated deficit	$ (28,050,541)	$ (20,626,799)

Summary of Significant Accoun_4

Summary of Significant Accounting Policies (Details) - shares	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Accounting Policies [Abstract]
Warrants to purchase Common Shares, less “penny warrants” included in potentially dilutive common shares	8,557,631	6,689,579
Common Shares issuable on exercise of options	2,668,866	1,400,967
Total potentially dilutive Common Shares excluded	11,226,497	8,090,546

Accrued Expenses (Details)

Accrued Expenses (Details) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Payables and Accruals [Abstract]
Employee compensation	$ 182,477	$ 263,914
Legal and consulting services	28,827	68,056
Clinical research organization services and expenses	590,290	16,877
Manufacturing expenses	14,000
Minimum license royalties	30,000
Total accrued expenses	$ 845,594	$ 348,847

Shareholders' Equity (Details)

Shareholders' Equity (Details) - Option [Member]	9 Months Ended
Shareholders' Equity (Details) - Option [Member]	Sep. 30, 2020$ / sharesshares
Total Options Outstanding
Beginning balance \| shares	1,661,466
Issued \| shares	1,255,000
Cancelled \| shares	(247,600)
Ending balance \| shares	2,668,866
Outstanding, vested and exercisable \| shares	1,037,227
Weighted Average Remaining Term (Years)
Outstanding Beginning	9 years 1 month 20 days
Outstanding Ending	8 years 4 months 2 days
Outstanding Ending, vested and exercisable	7 years 10 months 6 days
Weighted Average Exercise Price
Beginning balance	$ 3.38
Issued	1.44
Cancelled	3.27
Ending balance	2.48
Outstanding, vested and exercisable	2.63
Weighted Average Fair Value at Issue
Beginning balance	2.38
Issued	1.13
Cancelled	2.04
Ending balance	$ 1.78
Outstanding, vested and exercisable \| shares	2.22

Shareholders' Equity (Details 1

Shareholders' Equity (Details 1) - Black Scholes [Member]	9 Months Ended
Shareholders' Equity (Details 1) - Black Scholes [Member]	Sep. 30, 2020USD ($)$ / shares
Fair value of the options
Expected Term	5 years 9 months
Expected Dividend \| $
Minimum [Member]
Fair value of the options
Fair Value per Share	$ 1.36
Expected Volatility	102.39%
Risk free rate	0.49%
Maximum [Member]
Fair value of the options
Fair Value per Share	$ 1.48
Expected Volatility	103.83%
Risk free rate	0.72%

Shareholders' Equity (Details 2

Shareholders' Equity (Details 2) - USD ($)	3 Months Ended		9 Months Ended
Shareholders' Equity (Details 2) - USD ($)	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Total research and development expenses	$ 1,847,178	$ 864,280	$ 3,789,800	$ 2,761,630
Total general and administrative expenses	1,491,173	881,462	3,667,588	3,392,388
Total stock-based compensation expense			1,644,077	1,133,333
Stock Options [Member]
Research and development options expense	56,458	99,612	196,976	241,315
Total research and development expenses	56,458	99,612	196,976	241,315
General and administrative options expense	291,727	214,007	878,864	511,664
Stock and warrants issued to consultants and employees	329,807	71,250	685,238	380,354
Total general and administrative expenses	621,534	285,257	1,564,102	892,018
Total stock-based compensation expense	$ 677,992	$ 384,869	$ 1,761,078	$ 1,133,333

Shareholders' Equity (Details 3

Shareholders' Equity (Details 3) - Warrants [Member]	9 Months Ended
Shareholders' Equity (Details 3) - Warrants [Member]	Sep. 30, 2020$ / sharesshares
Total Warrants
Beginning balance \| shares	6,669,274
Issued \| shares	2,187,000
Exercised \| shares	(226,354)
Ending Balance \| shares	8,629,920
Weighted Average Remaining Term (Years)
Outstanding beginning	4 years 2 months 23 days
Outstanding ending	4 years 10 months 17 days
Weighted Average Exercise Price
Beginning balance	$ 5.38
Issued	1.98
Exercised	1.99
Ending balance	4.61
Average Intrinsic Value
Beginning balance	0.03
Ending balance	$ 0.08

Shareholders' Equity (Details T

Shareholders' Equity (Details Textual) - USD ($)	Sep. 21, 2020	Jun. 11, 2020	Feb. 22, 2019	Sep. 30, 2020	Sep. 29, 2020	Sep. 21, 2020	Jul. 31, 2020	Mar. 03, 2020	Jan. 31, 2019	Jan. 22, 2019	Oct. 09, 2017	Sep. 02, 2017	Sep. 30, 2020
Stockholders' Deficit (Textual)
Shares issued		2,820,000							22,311	250,000
Options for purchase													1,255,000
Warrants for purchase		$ 2,115,000		$ 226,354	$ 225,000		$ 1,354		$ 65,130	$ 300,000			$ 226,354
Equity-based compensation expense													1,420,505
Outstanding options intrinsic value				$ 1,051,006									1,051,006
Common stock exercise price		$ 2							$ 4.99	$ 3.75
Interest and financing charges
Exercise price					$ 2		$ 0.005
Weighted average remaining vesting period													1 year 9 months 25 days
Common stock, description			The Company concluded a follow-on offering of 2,475,000 shares of common stock and warrants to purchase 1,856,250 shares of common stock at an exercise price of $4.0625 per share. The shares of common stock and accompanying warrants were sold to the public at a price of $3.25 per share and warrant. The underwriters were granted an over-allotment option to purchase up to 371,250 shares of common stock and warrants to purchase 278,437 shares of common stock at a price of $3.25 per share of common stock and warrant. The underwriters partially exercised their over-allotment option by purchasing 370,000 shares of common stock and warrants to purchase 277,500 shares common stock. Gross proceeds of the offering, totaled $9,246,249, which after offering expenses, resulted in net proceeds of $8,195,673.					The Compensation Committee of Board of Directors of the Company awarded the Company's executive officers, William B. Stilley, Chief Executive Officer, and Joseph Truluck, Chief Financial Officer, performance bonuses for 2019, partially paid in common stock of the Company to preserve cash, of $42,000 and $21,000 in cash, respectively, and 54,167 and 27,084 shares of the Company's common stock, respectively, which shares are subject to a six-month contractual restriction on sale. Of the $180,002 total cost of these bonuses, $150,000 were recognized in the year ended December 31, 2019 as expected under these executives' contracts, and the remaining $30,002 in bonus was recognized upon Board approval.
Common stock market price		$ 1.85
Proceeds of offering, description	Gross proceeds of the offering totaled $500,000, with no material expenses.	Gross proceeds of the offering, totaled $5,217,000, which after offering expenses, resulted in net proceeds of $4,657,215.
Cash payment for warrants					$ 450,000		$ 8						$ 450,008
Unrecognized compensation expense													2,688,650
Consultants Services [Member]
Stockholders' Deficit (Textual)
Shares issued				446,251
Consultants at a total cost				$ 655,827									$ 655,827
Private Placement [Member]
Stockholders' Deficit (Textual)
Unregistered shares of common stock						357,143
Gross proceeds						$ 50,000
Option [Member]
Stockholders' Deficit (Textual)
Common stock exercise price				$ 1.13									$ 1.13
Common stock issued, shares													2,529,180
2017 Equity Incentive Plan [Member]
Stockholders' Deficit (Textual)
Common stock issued, shares											1,750,000	5,500,000	799,438
Common Stock \| Private Placement [Member]
Stockholders' Deficit (Textual)
Common stock market price	$ 1.40					$ 1.40
Consultant [Member]
Stockholders' Deficit (Textual)
Options for purchase													72,000
Warrants for purchase				$ 73,914									$ 73,914
Fair value of assumptions, description													Using the Black Scholes model assuming an underlying security value of $1.30 and volatility rate of 103.83%, a risk-free rate of 0.49%, and an expected term of 5.75 years.
Officers and Director [Member]
Stockholders' Deficit (Textual)
Common stock issued price										$ 468,750

Commitments and Contingencies_2

Commitments and Contingencies (Details)	9 Months Ended
Commitments and Contingencies (Details)	Sep. 30, 2020USD ($)
30% patients randomized [Member]
Milestone Event	30% patients randomized
Percent Milestone Fees	10.00%
Amount	$ 316,637
60% patients randomized [Member]
Milestone Event	60% patients randomized
Percent Milestone Fees	10.00%
Amount	$ 316,637
100% sites initiated [Member]
Milestone Event	100% sites initiated
Percent Milestone Fees	10.00%
Amount	$ 316,637
100% of patients randomized [Member]
Milestone Event	100% of patients randomized
Percent Milestone Fees	10.00%
Amount	$ 316,637
90% of case report form pages monitored [Member]
Milestone Event	90% of case report form pages monitored
Percent Milestone Fees	5.00%
Amount	$ 316,637
PE analysis [Member]
Milestone Event	PE analysis
Percent Milestone Fees	5.00%
Amount	$ 316,637
Database is locked [Member]
Milestone Event	Database is locked
Percent Milestone Fees	10.00%
Amount	$ 316,637

Commitments and Contingencies_3

Commitments and Contingencies (Details Textual)

Jul. 05, 2019

Dec. 14, 2017

Jun. 15, 2020USD ($)

Mar. 01, 2020USD ($)

Feb. 27, 2020USD ($)

Feb. 01, 2020USD ($)

Dec. 12, 2019

Sep. 30, 2019USD ($)

Jun. 28, 2019USD ($)

Jun. 28, 2019EUR (€)

Mar. 24, 2019USD ($)shares

Nov. 21, 2018USD ($)

Jan. 31, 2011

Sep. 30, 2020USD ($)$ / shares

Sep. 30, 2020EUR (€)

Sep. 30, 2019USD ($)

Jun. 15, 2020EUR (€)

Feb. 27, 2020EUR (€)

Feb. 01, 2020EUR (€)

Dec. 31, 2019USD ($)

Commitments and Contingencies (Textual)

Milestone payment

$ 20,000

Minimum license royalty expense

$ 10,000

$ 30,000

Prepaid research and development

214,409

536,916

Prepaid expenses

$ 294,124

(322,507)

$ (45,905)

Milestone payment associated, percentage

10.00%

Second Milestone [Member]

Commitments and Contingencies (Textual)

Prepaid expenses

$ 299,496

Third Milestone [Member]

Commitments and Contingencies (Textual)

Prepaid expenses

$ 297,013

Four Milestone [Member]

Commitments and Contingencies (Textual)

Prepaid expenses

$ 302,843

Sites, percent

50.00%

Purnovate, LLC [Member]

Commitments and Contingencies (Textual)

Monthly rent payment of lease

$ 1,400

Sublease, description

The Company entered into a sublease with Purnovate, LLC, a private company in which the Company’s CEO has a 30% equity interest, for the lease of three offices at 1180 Seminole Trail, Suite 495, Charlottesville, VA 22901. The lease has a term of two years, and the monthly rent is $1,400. During the three and nine months ended September 30, 2020, the rent expense associated with this lease was $4,200 and $9,800, respectively.

Consulting Agreement [Member] | Dr. Bankole A. Johnson [Member]

Commitments and Contingencies (Textual)

Consultant fees

$ 93,750

281,250

Annual salary

$ 375,000

Contract research organizations, description

The Company entered into a consulting agreement (the “Consulting Agreement”) with Dr. Bankole A. Johnson, who at the time of the agreement was serving as the Chairman of the Board of Directors, for his service as Chief Medical Officer of the Company. The Consulting Agreement has a term of three years, unless terminated by mutual consent or by the Company for cause. Dr. Johnson resigned as Chairman of the Board of Directors at the time of execution of the consulting agreement. Under the terms of the Consulting Agreement, Dr. Johnson’s annual fee of $375,000 per year is paid twice per month. On execution, Dr. Johnson received a signing bonus of $250,000 and option to purchase 250,000 shares of common stock. Dr. Johnson’s participation in the Grant Incentive Plan (see below) and 2017 Equity Incentive Plan continue unaffected. The total expense to the Company under this agreement was $93,750 and $281,250 in the three and nine months ended September 30, 2020, respectively.

Bonus

$ 250,000

Option to purchase | shares

250,000

Euro [Member] | Second Milestone [Member]

Commitments and Contingencies (Textual)

Milestone payment | €

€ 269,938

Euro [Member] | Third Milestone [Member]

Commitments and Contingencies (Textual)

Milestone payment | €

€ 269,938

Euro [Member] | Four Milestone [Member]

Commitments and Contingencies (Textual)

Milestone payment | €

€ 269,938

Service Agreement [Member]

Commitments and Contingencies (Textual)

Crown’s fee

$ 3,470,713

$ 3,717,114

Euro/US dollar exchange rate | $ / shares

$ 1.173

Prepayment under the agreement cost

$ 505,960

Service Agreement [Member] | Euro [Member]

Commitments and Contingencies (Textual)

Crown’s fee | €

€ 3,168,895

Euro/US dollar exchange rate | $ / shares

$ 1.173

Service agreement 1 [Member]

Commitments and Contingencies (Textual)

Cost of agreement

$ 362,188

$ 440,473

Estimated cost

2,500,000

Increasing estimated cost

2,900,000

Prepaid research and development

$ 214,633

Direct expenses

661,867

1,366,478

Accrued expense liability

$ 226,369

Service agreement 1 [Member] | Euro [Member]

Commitments and Contingencies (Textual)

Estimated cost | €

2,172,000

Estimated future site costs | €

344,768

Increasing estimated cost | €

€ 2,516,768

Master Services Agreement [Member]

Commitments and Contingencies (Textual)

Description of master services agreement

The Company entered into a Master Services Agreement (the “MSA”) and attached statement of work with Psychological Education Publishing Company (“PEPCO”) to administer a behavioral therapy program during the Company’s upcoming Phase 3 clinical trial. PEPCO is owned by a related party, Dr. Bankole Johnson, the Company’s Chief Medical Officer, and currently the largest stockholder in the Company. It is anticipated that the compensation to be paid to PEPCO for services under the MSA will total approximately $300,000, of which shares of the Company’s common stock having a value equal to twenty percent (20%) of this total can be issued to Dr. Johnson in lieu of cash payment.

Amendment Agreement [Member]

Commitments and Contingencies (Textual)

Amendment agreement, description

The Company entered into an Amendment (the “Amendment”) to the statement of work (“SOW”). The Company had paid PEPCO $39,064 under the SOW for services rendered as of the Amendment date, leaving as estimated balance of $274,779 to be paid under the SOW. The Amendment provided the Company with a 20% discount on the remaining fees owed for services and fixed the price of any remaining services at a total of $219,823 for all services required for the use of Brief Behavioral Compliance Enhancement Treatment (BBCET) in support of the Trial. In addition, Dr. Johnson executed a guaranty, dated December 12, 2019, of PEPCO’s performance under the MSA and SOW (the “Guaranty”), together with a pledge and security agreement, dated December 12, 2019 (the “Pledge and Security Agreement”), to secure the Guaranty with 600,000 shares of the Company’s common stock beneficially owned by him and a lock-up agreement, dated December 12, 2019 (the “Lock-Up”), pursuant to which he agreed not to transfer or dispose of, directly or indirectly, any shares of the Company’s common stock, as currently owned by him, until after January 1, 2021. On August 19, 2020, we entered into a Lock-Up Agreement Extension and Right of First Refusal with Dr. Johnson (the “Lock-Up Extension”), which amended the Lock-Up Agreement that had been entered into dated December 12, 2019 (the “Lock-Up”). The Lock-Up Extension extended the term of Dr. Johnson’s Lock-Up from January 1, 2021 until April 1, 2021. In connection with the Lock-Up Extension, Dr. Johnson was released from his Lock-Up restrictions with respect to 350,000 shares of the Company’s common stock. During the three and nine months ended September 30, 2020, the Company recognized $18,628 and $108,056, respectively, in expenses associated with this vendor agreement. As of September 30, 2020, the Company had recognized $147,120 in expenses, of which $108,056 were charged against cash advanced under the terms of the Amendment, leaving a net prepaid expense asset of $111,767 associated with this vendor agreement.

Licensing & Venture Group [Member]

Commitments and Contingencies (Textual)

License agreement description

The Company is obligated to pay UVA LVG yearly license fees and milestone payments, as well as a royalty based on net sales of products covered by the patent-related rights. More specifically, the Company paid UVA LVG a license issue fee and is obligated to pay UVA LVG (i) annual minimum royalties of $40,000 commencing in 2017; (ii) a $20,000 milestone payments upon dosing the first patient under a Phase 3 human clinical trial of a licensed product, $155,000 upon the earlier of the completion of a Phase 3 trial of a licensed product, partnering of a licensed product, or sale of the Company, $275,000 upon acceptance of an NDA by the FDA, and $1,000,000 upon approval for sale of AD04 in the U.S., Europe or Japan; as well as (iii) royalties equal to a 2% and 1% of net sales of licensed products in countries in which a valid patent exists or does not exist, respectively, with royalties paid quarterly. In the event of a sublicense to a third party, the Company is obligated to pay royalties to UVA LVG equal to a percentage of what the Company would have been required to pay to UVA LVG had it sold the products under sublicense ourselves. In addition, the Company is required to pay to UVA LVG 15% of any sublicensing income.

License agreement notice period, description

The license agreement may be terminated by UVA LVG upon sixty (60) days written notice if the Company breaches its obligations thereunder, including failing to make any milestone, failure to make required payments, or the failure to exercise diligence to bring licensed products to market. In the event of a termination, the Company will be obligated to pay all amounts that accrued prior to such termination.

License agreement amendment changed dates, description

The Company, using commercially reasonable efforts, was to achieve the goals of submitting a New Drug Application to the FDA for a licensed product to December 31, 2024 (from December 31, 2023) and commencing commercialization of an FDA approved product by December 31, 2025 (from December 31, 2024). If the Company were to fail to use commercially reasonable effort and fail to meet either goal, the licensor would have the right to terminate the license.